Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass

Morbid Obesity Clinical Trial

— LCD  

Official title:

The Effect of a 2-week vs. 6-week Low-calorie Diet (LCD) Followed by Roux-en-Y Gastric Bypass (RYGB) on Body Composition and Surgery Outcomes in Obese Humans: a Dietary Intervention and Magnetic Resonance Imaging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144597
• Other study ID #: CRO1668
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: February 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes. This study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI). The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further than the conventional food pre-operative diet.

Description:

The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will reassess at week 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients undergoing Roux-en-Y gastric bypass at Imperial Weight Centre

• aged 18 to 60 years

• boby mass index of 35 to 55 kg/m2

Exclusion Criteria:

• Claustrophobia

• Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging

• Current pregnancy or breast feeding for females (as determined by a pregnancy test)

• A full term pregnancy within the last year for females

• Treatment with any medication that might affect the study outcomes

• Haemorrhagic disorders and anticoagulant treatment

• History of cancer, excluding skin cancer

• History of severe or multiple allergies, severe adverse drug reaction or leucopenia

• Smokers

• Regular drinkers of more than three units of alcohol daily

• History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit

• Regular intake of over-the-counter (OTC) medication (other than the occasional paracetamol/aspirin)

• Poor compliers or subjects unlikely to commit to the 26 week study duration

• Blood donation within the 12 week period before the initial study dose

• Use of monoamine oxidase inhibitors (MAOIs) as anti depressant

Related Conditions & MeSH terms

• Liver Fat
• Morbid Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• Liquid formula low-calorie diet (LCD)
The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.

Procedure:
• Roux-en-Y gastric bypass (RYGB)
Participant went through Roux-en-Y gastric bypass (RYGB) surgery

Other:
• Control diet

Locations

Country	Name	City	State
United Kingdom	Imperial Clinical research facility	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Cambridge Weight Plan Limited

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Bottin JH, Balogun B, Thomas EL, Fitzpatrick JA, Moorthy K, Leeds AR, Bell JD, Frost GS. Changes in body composition induced by pre-operative liquid low-calorie diet in morbid obese patients undergoing Roux-en-Y gastric bypass. Obesity reviews (March 2014

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet	Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy	at 2 weeks or 6 weeks depending on group
Secondary	Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass	Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass	at 1-month following Roux-en-Y gastric bypass
Secondary	Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass	Intra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass	at 6 months following Roux-en-Y gastric bypass
Secondary	Complexity of Surgery	Complexity of surgery will be assessed by the surgeon at the time of surgery (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group) The complexity of the surgery was assessed through a score on a complexity scale based on questionnaires previously published by Anders Thorell"s and David Edholm"s groups (Edholm et al., 2011, Van Nieuwenhove et al., 2011). The scores (1-5) for 7 variables: exposure, bleeding, difficulty in dissection, difficulty in reconstruction, surgical judgment, technical demand and psychological stress were combined into a complexity of surgery score with a minimum of 7 (very little complexity) and a maximum of 35 (very high complexity).	at the time of surgery
Secondary	Operative Time	The operative time will be recorded at the time of surgery by the operating surgeon (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group)	at the time of surgery